Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05883969
Eligibility Criteria:
Inclusion Criteria:
Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B:
A. any two of the following:
* Neuroimaging predictive of a motor disability including the involvement of one or more of the following structures: sensori-motor cortex, basal ganglia, posterior limb of the internal capsule, pyramidal tracts.
* General Movement Assessment with absent fidgety GMs at fidgety age
* HINE scores \<57 at 3months or \<60 at 6months or \<63 at 9 months or \<66 at 12 months
B. both of the following:
* Unilateral brain injury on neuroimaging (MRI or ultrasound) predictive of CP
* Clinical signs of asymmetry
Exclusion Criteria:
* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
* Infants with other disability diagnoses e.g. Down Syndrome.
* children for whom neither parent is fluent in Danish.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Months
Study:
NCT05883969
Study Brief:
Protocol Section:
NCT05883969